Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
NCT ID: NCT03123354
Last Updated: 2018-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2015-05-01
2017-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Test group
All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.
O3 regional oximeter sensor
Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor
Interventions
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O3 regional oximeter sensor
Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor
Eligibility Criteria
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Inclusion Criteria
* 1 day to less than 18 years of age
* Weight between 3.5 and 40 kg
* Parental or legal guardian consent and subject assent
Exclusion Criteria
* Equal or more than 18 years in age
* Weight more than 40kg or less than 3.5kg
* Jaundice with bilirubin levels higher than the reference range
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent motioning of SpO2 levels during the study or placement of cerebral oximeter
1 Day
18 Years
ALL
No
Sponsors
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Masimo Corporation
INDUSTRY
Responsible Party
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Locations
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Stanford University
Stanford, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RAMA0003
Identifier Type: -
Identifier Source: org_study_id
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